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Denosumab-bbdz

(Jubbonti®)

Jubbonti®

Drug updated on 10/18/2024

Dosage FormInjection (subcutaneous; 60 mg/mL )
Drug ClassRANK ligand (RANKL) inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture
  • Indicated for the treatment of to increase bone mass in men with osteoporosis at high risk for fracture
  • Indicated for the treatment of of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • Indicated for the treatment of to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Indicated for the treatment of to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-5]
  • Bone Mineral Density (BMD) Improvement: Denosumab demonstrated the highest effectiveness in increasing total hip BMD in glucocorticoid-induced osteoporosis (GIOP) patients, with a SUCRA (LS) score of 99.7%. For lumbar spine BMD improvement, raloxifene was most effective with a SUCRA score of 98.5%.
  • Fracture Risk Reduction: Denosumab significantly reduced the risk of secondary vertebral fractures in patients with osteoporosis, with a relative risk (RR) of 0.41 (95% CI (Confidence Interval), 0.29-0.57, p < 0.0001). However, ibandronate and teriparatide were more effective in reducing non-vertebral fracture risks in GIOP patients.
  • Fall Incidence Reduction: A pooled analysis from five placebo-controlled trials indicated that denosumab reduced the incidence of falls, with a hazard ratio of 0.79 (95% CI, 0.66-0.93, p = 0.0061).
  • Serious Adverse Events of Infection (SAEI): Denosumab-treated patients experienced a slightly increased incidence of SAEI compared to placebo (RR 1.21; 95% CI 1.03-1.43; p = 0.02). Compared to bisphosphonates, denosumab was associated with a higher incidence of any infections (RR 1.11; 95% CI 1.02-1.20; p = 0.02).
  • General Adverse Events: No specific adverse event rates beyond infection data were provided, and no additional significant safety concerns were highlighted for denosumab compared to placebo or bisphosphonates.
  • There is no population types or subgroups information available in the reviewed studies.